GL-04-R3 Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach (2024 Mar) PUB

Name: GL-04-R3 Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach (2024 Mar) PUB
Creator: Health Sciences Authority
Keywords: guidances,guidelines,medical-devices,samd,software,software-as-a-medical-device

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Product Specific Regulatory Guidelines

Last updated

March 1, 2024

Description

Document focusing on SaMD specific regulatory guidelines.

Organization

Health Sciences Authority (HSA) 🇸🇬

Country / Region

Singapore

License

Other (Public Domain)

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1 Main file

GL-04-R3 Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach (2024 Mar) PUB

Updated on March 1, 2024

pdf (985.0KB)

URL: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gl-04-r3-regulatory-guidelines-for-software-medical-devices---a-life-cycle-approach-(2024-mar)-pub.pdf?sfvrsn=bbb0bdd2_4
Permalink: https://data.openrid.co/en/datasets/r/1998029e-dd91-4185-b5ae-4fc595cfcf37
MIME Type: application/pdf

Created on: March 17, 2024
Modified on: March 1, 2024

Size: 985.0KB

GL-04-R3 Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach (2024 Mar) PUB

Information

Type

Regulated products

Topics

Last updated

Description

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Organization

Country / Region

License

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